Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE Back to Search Results
Catalog Number 309605
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that one syringe 10ml ll tip bulk convenience pak has been found with a molding defect before use.The following has been provided by the initial reporter: it was reported that there is particulate found on the syringe.Per email: there is particulate on the top of the syringe from lot 9002961.
 
Event Description
It has been reported that one syringe 10ml ll tip bulk convenience pak has been found with a molding defect before use.The following has been provided by the initial reporter: it was reported that there is particulate found on the syringe.Per email: there is particulate on the top of the syringe from lot 9002961.
 
Manufacturer Narrative
Investigation: one photo and one empty tray without top web with a loose 10ml syringe inside were received.The sample was visually evaluated.The syringe was observed to have a molding flash on the plunger rod¿s thumb rest.The flash extended across the thumb rest and continued on two of the opposing ribs.The flash observed was outside of the allowed specification and is rejectable.Potential root cause for the flash defect is associated with the molding process.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8805472
MDR Text Key151562807
Report Number1213809-2019-00762
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096054
UDI-Public30382903096054
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number309605
Device Lot Number9002961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-